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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CYSB2500143 注射用伊尼妥单抗 Inetetamab Lyophilized Biological Products Supplementary Application 2025-07-01 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd view
JYHB2500336 艾曲泊帕乙醇胺片 eltrombopag olamine Tablet Chemical Drugs Supplementary Application 2025-06-25 Siegfried Barbera SL;Novartis Pharmaceutical Manufacturing LLC;Novartis Pharma Schweiz AG view
CXSL2500507 VUM02注射液 VUM-02 Injection Biological Products(1) New Drug Application 2025-06-23 Wuhan Guanggu Zhongyuan Pharmaceutical Co Ltd view
JYSB2500152 仑卡奈单抗注射液 lecanemab Injection Biological Products(1) Supplementary Application 2025-06-27 Biogen US Corp;Eisai Inc view
CYHS2502320 乙酰半胱氨酸注射液 acetylcysteine Injection Chemical Drugs(4) Generic Drug 2025-06-30 Beijing Continent Pharmaceuticals Co Ltd;Zhejiang Cdmo Pharmaceutical Co Ltd view
JYHZ2500123 阿奇霉素片 azithromycin Tablet Chemical Drugs(5.1) License Renew 2025-06-25 Pliva Croatia Ltd;Teva Pharmaceutical Information Consulting (Shanghai) Co Ltd view
CYHS2502317 普瑞巴林缓释片 pregabalin Tablet, extended release Chemical Drugs(3) Generic Drug 2025-06-28 CSPC OUYI Pharmaceutical Co Ltd view
CXSB2500108 HS-20137注射液 QX-004-N Injection Biological Products(1) Supplementary Application 2025-06-26 Shanghai Hansoh BioMedical Co Ltd;Changzhou Humon Pharmaceutical Co Ltd view
CYHS2502248 注射用赖氨匹林 Lysine Acetylsalicylate Lyophilized Chemical Drugs(3) Generic Drug 2025-06-23 Nanjing Huanglong Biotechnology Co Ltd;Shanxi PUDE Pharmaceutical Co Ltd view
CYHB2501273 西咪替丁片 cimetidine Tablet Chemical Drugs Supplementary Application 2025-06-28 Heilongjiang Haxing Pharmaceutical Co Ltd;Heilongjiang Jun'an Pharmaceutical Group Hongxiang Pharmaceutical Co Ltd view
CYHS2502256 硫糖铝口服混悬液 Sucralfate Suspension Chemical Drugs(3) Generic Drug 2025-06-24 Hefei Guogao Pharmaceutical Co Ltd;Yangzhou NO3 Pharmacitical Manufacture Co Ltd view
CXHL2500624 QLH12016胶囊 QLH-12016 Capsule Chemical Drugs(1) New Drug Application 2025-06-27 QILU Pharmaceutical Co Ltd view
CYHS2502326 硫酸特布他林口服溶液 terbutaline sulfate Oral solution Chemical Drugs(3) Generic Drug 2025-07-01 Jiangsu Omega Pharmaceutical Co Ltd;Zhengzhou Daruo Pharmaceutical Technology Co Ltd view
CXHL2500619 戊二酸利那拉生酯胶囊 linaprazan glurate Capsule Chemical Drugs(2.4) New Drug Application 2025-06-26 Shanghai Shengnuo Pharmaceutical Technology Co Ltd view
CYHB2501275 注射用盐酸头孢吡肟 cefepime hydrochloride Lyophilized Chemical Drugs Supplementary Application 2025-06-28 Guangzhou Baiyunshan Tianxin Pharmaceutical Co Ltd view
CXSL2500511 TQH2722注射液 TQH-2722 Injection Biological Products(1) New Drug Application 2025-06-24 Shanghai Zhengda Tianqing Pharmaceutical Technology Development Co Ltd view
CYHB2501257 磷酸奥司他韦胶囊 oseltamivir phosphate Capsule Chemical Drugs(4) Supplementary Application 2025-06-27 Sichuan Kelun Pharmaceutical Co Ltd view
CYHS2502327 磷酸奥司他韦胶囊 oseltamivir phosphate Capsule Chemical Drugs(4) Generic Drug 2025-07-01 Jiangsu Vanguard Pharmaceutical Co Ltd view
CYHS2502280 硫酸氢氯吡格雷片 clopidogrel bisulfate Tablet Chemical Drugs(4) Generic Drug 2025-06-26 Sichuan Xinsidun Pharmaceutical Co Ltd view
JYHZ2500129 米曲菌胰酶片 Tablet Chemical Drugs License Renew 2025-06-28 Nordmark Arzneimittel GmbH & Co KG;Bridging Pharma GmbH view